Breast cancer has the second highest cancer related death rate among the female population in the United States. This phenomenon has led to greatly increased use of mammography. The ability of mammography to detect suspect lesions has increased significantly since the late 1980's. Heretofore,the use of x-ray mammography coupled with ultrasound and hook and wire devices has improve the pre-operative localization of these suspect lesions. However, substantial inadequacies still exist with regards to the post-operative handling and analysis of surgical biopsy specimens.
One of the most relevant references which has attempted to address some of these inadequacies is Lary, U.S. Pat. No. 4,993,056, which discloses a specimen apparatus consisting of a board with an absorbent square attached thereto, radio-opaque indicia attached in proximity to the absorbent square, a compression sheet hingedly attached to the board and a means for removably attaching the compression sheet and board at a point distal from the hinge. However, close inspection of the radiologic and pathologic procedures for the location and analysis of lesions within a given specimen reveals a number of significant problems with this prior apparatus.
Once delivered to pathology, all surgical biopsy specimens must undergo a process in which the absolute margins of the specimens are painted with a dark indelible pigment such as india ink, tatoo powder or similar dye. Without this procedure which enables the identification of the outer-most edges of the biopsy specimen after sectional cuts are made, the pathologist could not ensure the surgeon that all of the lesion(s) was contained within the margins of the specimen. Regardless of the customary nature by which the pathologist inks a specimen, this procedure requires physical manipulation of the specimen prior to excision of the lesion(s). Because of this manipulation, the specimen is no longer in the same position as when the x-ray image was taken, and the location coordinates ascertained by Lary's device are thus rendered useless.
In addition, Lary teaches that the radio-opaque indicia consist of strips of copper with letters and numbers punched out. These strips are then attached to the adjoining edges of the absorbent square. The apparatus of Lary does not have grid lines throughout. This requires the radiologist to make a visual approximation of the lesion location from the indicia which may be quite distant from the lesion (up to 4 inches). The preciseness of an x-ray coordinates ascertained from this prior device is subject to question because in many instances the very suspect tissue may be no more than a series of micro-calcifications each having a diameter of less than 200 microns.
Lary also teaches that the board and compression sheet be comprised of a sandwich structure having an expanded polystyrene core and paper laminated to both sides of said core. Because the material specified for construction is opaque in nature, it is impossible to visually inspect the specimen within the device and thus a "focusing target" is required on top of the compression sheet of this prior device. Regardless of the addition of a target, without opening the hinged device and exposing the specimen, one cannot assure the exact location of the specimen on the absorbent blotter,cannot inspect the physical size of the specimen to determine appropriate kilo Voltage peak (kVp) and milli-Amperes per second (mAs) settings for imaging, and cannot visually inspect the specimen during compression to achieve optimal compression.
The specimen-holding apparatus of Lary, in and of itself, does not permit containment of fluids associated with specimens. This short fall requires that Lary's apparatus be placed in a clear polyethylene resealable bag which further impedes inspection of the specimen prior to imaging and can result in the possible dispersement of specimen fluids to the outer surfaces of the apparatus contained therein. With the present widespread concern about prevention of infection from blood-borne pathogens, proper containment of unidentified bodily fluids creates emotional as well as practical problems.
Lary's device further comprises a writing surface with diagrams which is separate from the primary apparatus designated for containment of the specimen. This presents the possibility for confusion of specimen identity and, ultimately, patient diagnosis.
Another reference to be noted is Garrigus, U.S. Pat. No. 4,837,795, which discloses a tissue specimen holding device consisting of three platens preferably fabricated from acrylic sheet measuring 0.25 inches, 0.50 inches and 0.25 inches respectively. Said platens are typically joined by nut and bolt assemblies, allowing the platens to be drawn towards one another "to compress the tissue specimen prior to radiographic exposure to squeeze excess fluids from the specimen and to flatten it to have substantially the same overall thickness and density." One of said platens contains a grid, dividing it into a plurality of regions. The grid is preferably fabricated from radio-opaque tape.
Several problems are associated with prior tissue specimen holding devices made in accordance with the Garrigus reference. The device of Garrigus is non-disposable. It requires cleaning and sterilization. The chance for foreign artifacts to be present in any radiographic image is increased. The possibility of cross contamination from specimen to specimen also exists. This prior device,like that of Lary, in and of itself, does not contain the fluids which are inherently associated with any surgical specimen. Any point of reference established through employment of Garrigus grid is lost when the specimen must be manipulated for pathologic examination. Because patient marking labels are not directly attached to the container in such prior devices, confusion of specimen identity may result. This prior device is equipment dependent,and special fabrications may be required depending on the size and shape of the mammographic film holder and compression paddle of any particular machine. In addition, this prior device comprises one inch of acrylic, which necessitates relatively high kVp setting in order to achieve proper exposer. This relatively high kVp in conjunction with the thickness of the device results in a high level of backscatter radiation, and ultimately results in low contrast and reduced detail resolution-both of which are critical to image evaluation.
Vitalini, U.S. Pat. No. 4,181,859 discloses a grid which is preprinted with radio-opaque ink and then attached to the x-ray film prior to exposure to enable two dimensional measurement of the x-ray image. It is adapted for use with flexible radiographic films commonly used in dentistry. This device allows the archival of a two dimensional measurement while the film undergoes considerable deformation commonly associated with dental exposures.
Another reference is Cherry, U.S. Pat. No. 3,547,121 which describes a radio-opaque grid for use with x-ray positioning and needle placement for fetal transfusions. Said grid is placed on the abdomen of the pregnant patient to aid in the location of the fetus to receive the needle from within the peritoneal cavity.
A further referenced is Gabriele et al. U.S. Pat. No. 4,691,333 which discloses a perforated strap compression device used for needle localization in conjunction with a mammography film cartridge.
Another reference is Ammerman, U.S. Pat. No. 4,723,974 which discloses a flexible container which provides a cool compartment for the transport of amputated extremities.
A similar reference is Winchell, U.S. Pat. No. 4,474,016 which discloses a sterile cooling system for organs during transplant operations.
Yet another reference is Bliss, U.S. Pat. No. 2,399,424 which discloses measurement indicia on the side of x-ray film to determine foot size for the fitting of shoes.